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OpenTrials
Completed

NCT Number: NCT05766332

Evaluating Clinical Evaluation Tools for Predicting Risk of Complications After Hematopoietic Stem Cell Transplant

This study evaluates whether clinical evaluation tools such as the six-minute walk test, hand grip strength test, and gait speed test, are useful in predicting risk of complications in patients undergoing hematopoietic stem cell transplants (HCT). Being able to predict who is at increased risk of post-HCT complications can help better inform patients and providers on the risks and benefits of undergoing HCT and determine whether certain patients should have closer post-HCT monitoring due to an increased risk of complications.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

PRIMARY OBJECTIVE:

I. To develop novel pre-transplant tools for determining risk of post-HCT pulmonary complications.

OUTLINE: This is an observational study.

Patients undergo a clinical evaluation consisting of a six-minute walk test, hand grip strength test, and gait speed test on study. Patients' medical records are also reviewed for a year on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age >= 18 years old)
  • Undergoing evaluation for autologous or allogeneic bone marrow transplant (HCT) at Mayo Clinic Rochester
  • Scheduled for pre-HCT pulmonary function test by the primary team

Exclusion criteria

  • Limited mobility requiring use of gait aid or wheelchair
  • Fall risk

Treatment and study plan

Clinical evaluation

Other

Undergo clinical evaluation

Other names: Clinical Assessment

Electronic Health Record Review

Other

Medical records reviewed

Primary outcomes

  1. Pulmonary complication following hematopoietic stem cell transplant (HCT)

    Time frame: Up to 1 year after transplant

    Pulmonary complications may include but are not limited to: infection, HCT-specific lung injury syndromes, acute respiratory distress syndrome, pulmonary graft versus host disease. Univariable analysis will be first used to identify potential factors that predict post-HCT pulmonary complications. All possible factors will then be included in multivariable analysis. Will also specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.

Secondary outcomes

  1. 100-day mortality

    Time frame: At 100 days after transplant

    Analyses similar to those for the primary outcome will be conducted.

  2. 1 year mortality

    Time frame: At 1 year after transplant

    Analyses similar to those for the primary outcome will be conducted.

  3. Relapse-free survival

    Time frame: At 1 year after transplant

    Analyses similar to those for the primary outcome will be conducted.

  4. Hospital or intensive care unit admission post-HCT

    Time frame: Up to 1 year after transplant

    Will specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.

  5. Need for noninvasive or invasive mechanical ventilation

    Time frame: Up to 1 year after transplant

    Will specifically test whether the six-minute walk test, grip strength and gait speed add additional significance to pulmonary complications and the statistic model after including pulmonary function test results.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Developing Novel Tools for Determining Risk of Respiratory Complications Following Hematopoietic Stem Cell Transplant

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2023
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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